Various devices have been proposed in past years for directing and collecting urine from female patients suffering from urinary incontinence but, in general, such devices have been associated with problems of leakage, wearer discomfort, pressure sores, and even necrosis Lack of commercialization is evidence of the ineffectiveness of earlier devices.
Prior patents have disclosed female urinary collection devices equipped with locating elements intended to be inserted into the vagina for retaining the collection devices in operative positions. Reference may be had, for example, to U.S. Pat. Nos. 2,483,079, 3,776,235 and 4,198,979. Constructions with relatively rigid locating elements clearly fail to conform with the anatomical changes occurring during body movement; other devices with flexible or deformable vaginal locating elements may reduce tissue irritation and increase patient comfort, but problems in providing an effective seal and avoiding leakage along the lines or zones of contact nevertheless remain.
U.S. Pat. No. 4,198,979 discloses a rigid-type collection device with a pommel for vaginal insertion. The orifice of the rigid collector is covered with a sealant layer of body adhesive for contact with vestibular tissue. U.S. Pat. No. 3,683,914 presents a device with an enlarged vaginally-insertable portion with a separate passage leading to a collection tube. U.S. Pat. Nos. 4,421,511 and 3,194,238 both disclose female incontinence devices with inner cups or funnels intended to engage the periurethral floor and external pads engagable with a wearer's skin about the labia majora. A suitable harness or belt is then worn to help hold the external and internal elements in place.
Published British application No. 2,090,741A discloses an incontinence device having an adhesive pad of triangular shape intended to engage periurethral tissue. British application No. 2,015,374A shows an incontinence device including an adhesive pad with a ridge-like projection dimensioned to extend between the labia majora of a wearer. U.S. Pat. No. 4,563,183 shows a female external catheter with an intralabial adhesive body for engaging the vestibule and an interlabial adhesive body that overlies and adhesively contacts the external aspects of the labia minora.
Co-pending co-owned U.S. Pat. No. 4,681,572, discloses a female urinary incontinence device having a periurethral cup, an external pad, and an elastic tubular bellows extending between the cup and pad. The periurethral cup is molded in one piece from soft compressible material having a durometer within the range of about 10 to 30 on the Shore A scale and has walls of substantial thickness providing smoothly rounded surfaces for sealingly contacting surfaces of the periurethral floor and vaginal introitus. One wall portion of the cup curves upwardly to define a resilient urine-reflecting protuberance received within the vaginal introitus. The external pad is held in place by a panty or belt to keep the bellows in a state of partial compression, the compressed bellows in turn holding the periurethral cup in proper position.
Other patents of interest are U.S. Pat. Nos. 4,270,539, 4,496,355, and published British application No. 2,070,936A.
The incontinence device of this invention includes a periurethral cup that is formed from highly resilient and deformable material and has a configuration similar to the cup disclosed in the aforementioned co-pending patent. However, there is no resilient bellows, nor must there be any external pad or other direct external retention means. Two zones of adhesive contact effectively maintain the cup in place.
Specifically, a first resilient adhesive pad extends about the neck portion of the periurethral cup and has a pair of side sections with enlarged laterally and outwardly facing surfaces for adhesively engaging the inwardly-facing surfaces of the labia minora of the patient. While the first adhesive pad may also contact the inwardly-facing or opposing surfaces of the labia majora, such pad is in any event enclosed between the labia minora when the device is properly worn. The pad may take the form of a band of adhesive material wrapped about the neck portion of the periurethral cup with the ends of the band joined together to form a double-thickness flap projecting forwardly from the cup's neck portion.
The second resilient adhesive pad is of annular shape and is affixed to the rim of the periurethral cup for adhesively and sealingly engaging the periurethral floor. It has been found that the first sealing zone performs a retentive function that cannot be accomplished by the second zone alone, and that the two zones coact to maintain the cup in effective sealing contact with a wearer.
The device also includes a detachable coupling in close proximity to the periurethral cup. Adjacent the point of detachable interconnection are a one-way membrane flap valve, which prevents backflow that might otherwise disrupt the adhesive seals, and a disc-equipped vent valve which blocks the escape of urine but allows entry of ambient air to provide vacuum relief even at extremely low rates of urinary flow. Other features, advantages, and objects of the invention will become apparent from the specification and drawings.